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Bracing and Reconstruction for ACL Injuries

This study, called the BRACE-trial, is looking at whether using a special brace after surgery helps people who have torn their anterior cruciate ligament (ACL) (a major knee ligament). Specifically, it's comparing quadriceps autograft ACL reconstruction (a type of surgery using your own thigh muscle tendon) with and without a post-surgical functional brace (DonJoy Defiance Pro brace). The study wants to see if bracing helps with how well people recover, their psychological readiness to return to sports, and how many people successfully get back to sports. You might be able to join if you are 14 to 39 years old, have a complete ACL injury in one knee, play sports, and are having this specific type of ACL surgery. The study plans to enroll 96 participants, but its current status is unclear.

Study design
This is an interventional study planning to enroll 96 participants. It is a randomized controlled trial, meaning participants will be randomly assigned to receive either the brace or no brace after surgery.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 24 months (2 years) after their surgery to assess their recovery and return to sports.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06942754

Bracing and Reconstruction of the Anterior Cruciate Ligament for Efficacy Trial

Recruiting
NAAges 14–39InterventionalSupportive care
Wake Forest University Health Sciences
~96 participants
Updated 2026-04-01 on ClinicalTrials.gov
What's tested:post-surgical functional bracing

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in ACL-return to sport index (ACL-RSI) Scores
Measured over Baseline and 3, 6, 12, and 24 months

Conditions

Anterior Cruciate Ligament Injuries

Explore related trials

Injury of anterior cruciate ligament

NCT06942754

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolinastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Brian Waterman, MD · PRINCIPAL_INVESTIGATOR · Wake Forest University Health Sciences

Who to contact

Katherine Leonard
[email protected]
336-716-3952
Email the study team

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Eligibility criteria

Inclusion

patients with unilateral complete ACL injury
patients involved in sports and the desire to return to sports
patients undergoing quadriceps autograft ACL reconstruction
must be 14 to 39 years old

Exclusion

multiligamentous knee injuries defined as two ligaments requiring surgical stabilization
concomitant suture tape augmentation, extra-articular tenodesis or anterolateral ligament reconstruction
concomitant femoral, tibial, or patellar fracture(s)
patients with significant osteoarthritis
concomitant ipsilateral knee dislocation or patellar dislocation
significant lower leg malalignment requiring correcting osteotomies
prior ACL surgery, including contralateral knee
pregnancy during injury or surgery
unable to provide consent
prolonged use of prednisolone or cytostatics
comorbidities (e.g., muscular, neurological, vascular) that influence rehabilitation

What this trial measures

  • Change in ACL-return to sport index (ACL-RSI) ScoresBaseline and 3, 6, 12, and 24 months

    The ACL-Return to Sport after Injury scale (ACL-RSI) is a 12-item survey that measures psychological readiness to return to sport after an ACL injury or surgery. It uses a visual analog scale from 0 to 100, where higher scores indicate greater psychological readiness. The total score is calculated as a percentage of the 12-item total score. A higher ACL-RSI score indicates a greater level of psychological readiness for returning to sport.